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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01634204
Other study ID # KiloCoach
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received July 3, 2012
Last updated July 5, 2012
Start date September 2011
Est. completion date July 2013

Study information

Verified date July 2012
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority Germany: Berliner Datenschutzgesetz (BlnDSG)
Study type Interventional

Clinical Trial Summary

Since overweight and obesity, a risk factor for various diseases, is a prevalent problem in the modern society, it is important to search for new strategies to counteract this. In contrast to in person support, the internet provides a low cost opportunity, which is able to reach a large part of the population. Therefore a web-based weight loss program may be an adequate mean for many people. Now it is hypothesised that a web-based weight loss program is able to support a reduction of body weight and weight-related cardiovascular risk factors effectively and to promote a healthier lifestyle. It is expected that program use, compared to a control group, results in greater reductions in body weight and cardiovascular risk.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date July 2013
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- age 30-65 years

- body Mass Index: 27-39,9 kg/m2

- ECOG-Performance status degree 0 or 1

- basal internet skills

- private internet access

- signed informed consent

Exclusion Criteria:

- malign diseases

- major organ diseases

- inflammatory bowel diseases

- insulin - dependent diabetes mellitus

- pregnancy, breast feeding

- treatment of eating disorders (e.g. bulimia, anorexia nervosa) within past 5 years

- parallel participation in other weight loss programs or other trials

- weight loss > 5% within past 6 month

- chronic therapy with glucocorticoids

- subjects treated because of psychiatric disorders (e.g. schizophrenia, bipolar disorder) in the past

- subjects with expected non-compliance to protocol guidelines

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
KiloCoach
Study participants in this arm will use the program to record nutrition and physical activity on at least 4 days per week within the first and ad libitum within the second 3 months of the intervention period. Study visits will be conducted at baseline as well as after 1, 3 and 6 months. After 12 months a follow up visit will be conducted.
Control
Study subjects try to reduce their body weight on their own. They are free to exercise and/or change nutritional habits. Not allowed is taking part in any structured weight loss program. Study visits will be conducted at baseline as well as after 1,3 and 6 months. A follow up visit will be conducted after 12 months.

Locations

Country Name City State
Austria KiloCoach e.U. Vienna
Germany Charité- Universitätsmedizin Berlin Berlin
Germany University Hospital Regensburg Regensburg

Sponsors (3)

Lead Sponsor Collaborator
Charite University, Berlin, Germany KiloCoach e.U., University Hospital Regensburg

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (10)

Galanis DJ, Kolonel LN, Lee J, Le Marchand L. Anthropometric predictors of breast cancer incidence and survival in a multi-ethnic cohort of female residents of Hawaii, United States. Cancer Causes Control. 1998 Mar;9(2):217-24. — View Citation

Goldstein DJ. Beneficial health effects of modest weight loss. Int J Obes Relat Metab Disord. 1992 Jun;16(6):397-415. Review. — View Citation

Harvey-Berino J, Pintauro S, Buzzell P, DiGiulio M, Casey Gold B, Moldovan C, Ramirez E. Does using the Internet facilitate the maintenance of weight loss? Int J Obes Relat Metab Disord. 2002 Sep;26(9):1254-60. — View Citation

Harvey-Berino J, West D, Krukowski R, Prewitt E, VanBiervliet A, Ashikaga T, Skelly J. Internet delivered behavioral obesity treatment. Prev Med. 2010 Aug;51(2):123-8. doi: 10.1016/j.ypmed.2010.04.018. Epub 2010 May 15. — View Citation

Krukowski RA, Harvey-Berino J, Ashikaga T, Thomas CS, Micco N. Internet-based weight control: the relationship between web features and weight loss. Telemed J E Health. 2008 Oct;14(8):775-82. doi: 10.1089/tmj.2007.0132. — View Citation

Longin R, Grasse M, Aspalter R, Waldherr K. Effectiveness of the online weight reduction program KiloCoachâ„¢ and comparison with other evaluated commercial direct intervention and online programs. Obes Facts. 2012;5(3):372-83. doi: 10.1159/000339726. Epub 2012 Jun 14. — View Citation

Tate DF, Jackvony EH, Wing RR. A randomized trial comparing human e-mail counseling, computer-automated tailored counseling, and no counseling in an Internet weight loss program. Arch Intern Med. 2006 Aug 14-28;166(15):1620-5. — View Citation

Tate DF, Wing RR, Winett RA. Using Internet technology to deliver a behavioral weight loss program. JAMA. 2001 Mar 7;285(9):1172-7. — View Citation

Trentham-Dietz A, Newcomb PA, Egan KM, Titus-Ernstoff L, Baron JA, Storer BE, Stampfer M, Willett WC. Weight change and risk of postmenopausal breast cancer (United States). Cancer Causes Control. 2000 Jul;11(6):533-42. — View Citation

Truby H, Baic S, deLooy A, Fox KR, Livingstone MB, Logan CM, Macdonald IA, Morgan LM, Taylor MA, Millward DJ. Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials". BMJ. 2006 Jun 3;332(7553):1309-14. Epub 2006 May 23. Erratum in: BMJ. 2006 Jun 17;332(7555):1418. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary body weight reduction in % after 3 months No
Secondary body weight reduction in % after 6 and 12 months No
Secondary cardiovascular risk Cardiovascular risk is assessed by hsCRP, Fetuin A, LDL/HDL-ratio, waist-to-hip-ratio, HOMA-IR, blood pressure, body mass index, lean body mass (LBM), fat mass (FM), body cell mass (BCM.) after 3,6 and 12 months No
Secondary Quality of life Quality of life is assessed by "Obesity and Weight-Loss Quality of Life-Instrument" and "Weight related symptom measure". after 3,6 and 12 months No
Secondary Nutrition and physical activity Nutritional intake (controls) is assessed by 3-day dietary protocols. Physical activity is assessed by "International physical activity questionnaire" (IPAQ-long), lower limb strength and phase angle. after 3,6 and 12 months No
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